Abbott recalls Alinity m System (REF 08N53-002) for incorrect optical calibration that may affect diagnostic accuracy. No immediate action needed but check for serial number 00654.
Incorrect optical calibration
Abbott is recalling the Alinity m System (REF 08N:002) due to incorrect optical calibration, which could lead to inaccurate diagnostic results. This affects laboratory equipment used for in vitro diagnostics.
Incorrect optical calibration can cause the system to produce inaccurate diagnostic results. This may lead to incorrect medical decisions if the equipment is used for critical testing.
Laboratories using the Alinity m System for in vitro diagnostics are affected. Users most at risk are those relying on accurate test results for medical diagnosis.
Check for the model reference 08N53-002 and serial number 00654 on the device. The product is used for in vitro diagnostic purposes.
Look for the model reference 08N53-002 and serial number 00654 on the Alinity m System.
The recall is for incorrect optical calibration that may affect diagnostic accuracy, but no immediate action is needed.
Check for the model reference 08N53-002 and serial number 00654 on the Alinity m System.
No immediate action is required, but check the device details to confirm if it is recalled.
We’ve drafted a message you can send Abbott Molecular to request your refund or repair — edit it as you like.
Subject: Recall Z-1518-2022 — Abbott Molecular Abbott Molecular Hello, I own a Abbott Molecular that is covered by recall Z-1518-2022 from Abbott Molecular. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
